Status:
ENROLLING_BY_INVITATION
Interleukin-15 to Promote Post-ART Control of HIV
Lead Sponsor:
Michael Peluso, MD
Collaborating Sponsors:
amfAR, The Foundation for AIDS Research
Conditions:
HIV
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Even though HIV medicine stops the virus from making more copies of itself, the virus remains in the body by hiding inside of immune cells. This hidden virus is referred to as the "latent reservoir." ...
Eligibility Criteria
Inclusion
- Key
- Age ≥ 18 and ≤ 70 years at the time of screening
- Documented HIV-1 infection
- On continuous ART for at least 6 months without any interruptions of greater than 14 consecutive days within the preceding 6 months
- Plasma HIV RNA levels less than 200 copies/mL at each determination in the previous 6 months
- Screening CD4+ T-cell count ≥ 350 cells/mm3
- Willingness to interrupt ART as part of the study transient treatment interruption
Exclusion
- On an ART regimen that includes a non-nucleoside reverse transcriptase inhibitor, unable to switch to a different regimen
- Receipt of any long-acting ART medication (e.g., injectable cabotegravir/rilpivirine, lenacapavir) in the two years preceding screening.
- Known resistance to two or more classes of ART drugs and/or the inability to construct another fully suppressive regimen
- Evidence of HIV "elite" control immediately prior to ART initiation
- Screening platelets \< 125,000/mm3
- Screening hemoglobin \< 12.5 g/dL for men and \<11.5 for women
- History of an AIDS-defining illness according to CDC criteria
- History of HIV-associated malignancy
- Non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months preceding screening, or for whom such therapies are expected in the subsequent 12 months.
- Active Hepatitis B (Hep B) infection (defined as Hep B surface antigen (sAg) positive or HBV DNA positive)
- Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA)
- Chronic liver disease
- Chronic kidney disease
- Active and poorly controlled atherosclerotic cardiovascular disease
- QTc interval \>450msec (male) or \>470msec (female)
- Pregnant, breastfeeding, or unwilling to use contraception to prevent pregnancy during participation in the study and until 6 months resumption of ART
- Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) in the partner, with sexual partners not known to have HIV
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07145164
Start Date
September 1 2025
End Date
December 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
UCSF
San Francisco, California, United States, 94044